PT549 – Why Did the FDA Reject MDMA-Assisted Therapy for PTSD?, with Ingmar Gorman, Ph.D.
Sep 20, 2024
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Ingmar Gorman, Ph.D., a clinical psychologist and co-founder of a psychedelic education company, shares insights on the FDA's controversial rejection of MDMA-assisted therapy for PTSD. He explains the intricacies surrounding the accusations faced by the therapy and the challenges in studying adverse experiences. Gorman also critiques the impact of public scrutiny and emphasizes the need for balanced media narratives. He calls for deeper journalist research to move beyond sensationalism and highlights the importance of acknowledging the human stories in psychedelic therapy.
Ingmar Gorman attributes the FDA's rejection of MDMA-assisted therapy for PTSD to complex issues surrounding regulatory transparency and institutional conflicts.
The podcast stresses the importance of critical evaluation in public discourse, highlighting how misinformation can harm the reputations of researchers and therapists involved in psychedelic trials.
Gorman introduces the concept of 'inner healing intelligence' in psychedelic therapy, emphasizing participant empowerment and the need for nuanced therapeutic approaches.
Deep dives
Background and Involvement in Psychedelic Therapy
Ingmar Gorman, a clinical psychologist, has been involved in psychedelic research and therapy since 2006, specifically with MDMA-assisted psychotherapy trials for PTSD. As a co-principal investigator and study therapist, he played a vital role in various phases of these studies. His experience also led him to establish Fluence Training, a company dedicated to training mental health professionals in psychedelic therapy and harm reduction. Currently, Fluence collaborates with several drug sponsors to enhance psychotherapeutic methodologies for clinical trials.
Challenges Faced by Lycos and the FDA Decision
The discussion reveals complexities surrounding the FDA's recent decision not to approve the new drug application for Lycos, cited as a multifactorial issue. Key players such as ICER and conflicting communications between various organizations contributed to the perceived downward trajectory for Lycos. Gorman emphasizes the importance of transparency and proactive communication, asserting that mistakes made by Lycos, while significant, were not solely responsible for the unfavorable outcome. The overwhelming vote from the FDA advisory committee against approval left little room for regulatory leniency.
Impact of Misinformation and Public Perception
Public discourse regarding Lycos has been heavily influenced by misinformation and sensationalist narratives perpetuated by certain media outlets and organizations. Gorman stresses the need for critical evaluation of claims surrounding unethical practices, arguing that many criticisms stem from misinterpretations by individuals lacking expertise in clinical trial methodologies. He highlights that while critiques of institutional processes are essential, they can inadvertently harm the dedicated therapists and researchers working to support patient health. This situation underscores the significance of responsible communication and the potential consequences of public allegations.
Therapeutic Approaches and Healing Mechanisms
The conversation introduces the concept of 'inner healing intelligence' as a metaphorical aspect of psychedelic therapy, with Gorman arguing that therapeutic relationships empower participants during their healing process. He draws contrasts between traditional psychiatric approaches and the nuanced client-centered techniques employed in psychedelic therapy that emphasize autonomy and empowerment. This recognition of participant agency aims to create safer and more supportive environments, ultimately improving therapeutic outcomes. Gorman advocates for a more profound understanding of these methodologies to counteract claims that mislabel them as cult-like practices.
Future Directions for Psychedelic Research
The ongoing exploration of new therapeutic compounds alongside psychedelic substances signifies a burgeoning landscape in mental health treatment. Gorman notes that various drug developments and their potential impacts must be evaluated in the context of current societal challenges, particularly the mental health crisis. He expresses hope for the approval and acceptance of psychedelic therapies despite the hurdles posed by regulatory frameworks. The conversation concludes by emphasizing the importance of collaboration and mutual support within the psychedelic community to ensure that promising treatments can reach those in need.
In this episode, Joe interviews Ingmar Gorman, Ph.D.: clinical psychologist and co-founder and CEO of Fluence, a psychedelic education company.
Gorman served as a co-principal investigator and study therapist on MAPS’ Phase II and III clinical trials for MDMA-assisted psychotherapy for PTSD, and works with drug sponsors: training, developing the components for clinical trials, and designing therapy manuals. With his insider’s perspective, he discusses the reasons why he believes the FDA rejected MDMA-assisted psychotherapy for PTSD: from ICER’s 2.1 section of the report giving legitimacy to allegations they don’t have the authority to research, to Lykos not being able to defend some accusations due to confidentiality, to the damage caused over time (which likely influenced the decision) from attacks against Lykos from dissenters.
He discusses:
How, despite abuse claims, the main allegations in the report were actually about the mishandling of data or influence of investigators on participants
The complications of needing to follow study frameworks: Should your adverse experience be in the report if it happened outside the study window?
How easily opposition can attack and demonize a faceless company, while forgetting the humanity of the people behind it
Inner healing intelligence and the proposition that people have been indoctrinated into this concept by MAPS
The need for journalists to research more and not just jump on a narrative